What is Irritable Bowel Syndrome (IBS)?

Irritable Bowel Syndrome (IBS) is a common intestinal ailment affecting nearly 15% of the US population.

It is classified as a functional bowel disorder, meaning that the muscles in the intestines or the nerves that control the intestines are not working properly, causing the intestines to function abnormally. Irritable bowel syndrome is characterized by a group of symptoms in which abdominal pain or discomfort is associated with a change in bowel pattern, such as loose or more frequent bowel movements, diarrhea, and/or constipation. The causes of IBS are largely unknown.

There are a number of symptoms relating to IBS, with the most common being abdominal pain and discomfort with no physical cause found. Other signs and symptoms of IBS include abdominal distention, nausea, vomiting, diarrhea, and constipation. Studies have shown that patients diagnosed with IBS tend to produce larger amounts of intestinal gas than people without IBS, retaining the gas in the small intestine for longer periods of time. This intestinal gas retention causes the abdomen to increase in size during the day, reaching the maximum in the evening and returning to normal size by morning. The onset of IBS and the accompanying symptoms usually occurs in early adulthood.

The treatment of IBS is difficult, due to the very small amount of medications that have been studied or found effective in treating IBS. To date, only one medication has been approved by the US Food and Drug Administration (FDA) for use in the treatment of IBS. That medication is Zelnorm, manufactured and marketed by Novartis Pharmaceuticals and approved for release to the public in August of 2002.

Zelnorm (generically known as tegaserod maleate) is a drug prescribed to treat severe, chronic IBS with constipation being the main issue. It is only prescribed for women, as studies have shown no beneficial effects for men. The drug works by increasing the activity of serotonin in the bowels, increasing the speed at which stool moves through the bowels. With effective treatment, Zelnorm reduces abdominal pain, discomfort, bloating, and constipation associated with IBS. It is not effective in all cases and is not considered a cure for IBS.

The common side effects associated with Zelnorm are back or joint pain, nausea, headache, dizziness, abdominal pain, and excessive flatulence. Diarrhea is commonly noted during the first week of treatment, but in most cases, it gradually disappears as treatment continues. A more serious side effect attributed to Zelnorm is ischemic colitis, a serious condition resulting from lessened blood flow to the intestines, which can cause intestinal damage and serious complications. The symptoms of ischemic colitis include fever, new or worsening abdominal pain, vomiting, low back pain, and bloody diarrhea. If left untreated, it can cause a need for immediate surgical procedures and in rare cases, death.

On March 30, 2007, Novartis Pharmaceuticals announced that, per a request by the FDA, they would discontinue selling and marketing Zelnorm in the United States. Recent clinical trials have found a connection between Zelnorm and a higher risk of serious cardiovascular events, such as heart attacks, strokes, or unstable angina (chest pain that can progress to a heart attack). The data was collected from 29 separate clinical trials conducted to assess the risks of prescribing Zelnorm for different types of gastrointestinal problems. The trials discovered that many more adverse cardiovascular events were experienced by patients taking Zelnorm, compared to the patients taking a placebo. As a result of this new information, the FDA came to the conclusion that, overall, the risks for Zelnorm outweighed the benefits of taking the medication and requested that sale of the medication be halted pending further investigation.

Do I have a Zelnorm Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Zelnorm lawsuits. We are handling individual litigation nationwide and currently accepting new Zelnorm cases in all 50 states.

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular side effect, you should contact us immediately. You may be entitled to compensation and we can help.